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NOLAN: Naproxen or Loratadine and Neulasta

NCT01712009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-01-30

Study results available
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Summary

The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.

Conditions

  • Bone Pain in Stage I - III Breast Cancer

Interventions

DRUG

Naproxen

DRUG

Loratadine

BIOLOGICAL

Pegfilgrastim

Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.

DRUG

Chemotherapy

The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-01
Primary Completion
2015-03-18
Completion
2015-03-18

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01712009 on ClinicalTrials.gov